Discover Your “WHY”

Topic: Discover Your “WHY”
Presented by: Frumi Barr, PhD

December 11 – December Social Dinner Meeting

Our Section’s December program is designed for the entire family. Having a purpose is critical to happiness, passion, and achieving dreams. Do you understand your “Why?” Let Dr. Frumi Barr introduce you to your “WHY.” Bring your significant other, your friends, your family to an evening filled with great people, delicious food – appetizers and dinner at a value that represents our gift to you. Remember last December – it will be the same format.

The people who inspire us are not driven by what they do, they are driven by WHY they do it. The Why Institute guides leaders to discover and then implement their “Why” or cause. We inspire them to shape their own futures, take decisive action and maintain their momentum.

The 5 Success Habits of High Performance Teams

December 7, 2012 – Educational Seminar

Topic: The 5 Success Habits of High Performance Teams Full Day SeminarPresenter: Chris Alexander

There is no difference between a high-performance business team and a team of Olympic athletes. In business as with world-class sports teams, teamwork is a competitive advantage. The NYFD and other emergency workers on 9/11 succeeded in saving many lives by working in teams. NASA has been teaching astronauts to work in teams since Neil Armstrong and the Apollo 11 employees made teamwork a major success factor.

When a group of individuals comes together behind a common set of goals and core values, barriers are broken and magic is in the air . . . and customers can sense it and benefit from it.

Voice of the Customer

This is our regular monthly dinner meeting program with two clinics running concurrently, dinner, and an outstanding after dinner presentation. You are welcome to come for the clinics and after dinner presentation WITHOUT buying the dinner. In fact, we welcome you. We will have accommodations for you. This way you still earn the RU and take advantage of the presentations.

Change-Is It Always Good?

ASQ Section 711 presents…

Change-is it always good? A non-political seminar by Jeff Croddy

Change. Why does everything have to change? Everything ran so well, then bang!, some new idea comes down from the boss. Sound familiar? Change is the ever-present vehicle that is both heralded and blamed for successes and failures alike.

With the elections now over, the celebrations and blame storming in full swing, it is the perfect time to look at why change happens. As we approach the new year, even more change will occur. The real question is, now we can make a conscious decision to understand and determine, how do we respond to change and what control we all have over change.

Reservations are not required. Upon arrival, announce that you are with ASQ.

Join us at the Home Town Buffet in Corona Hills Plaza, Corona, CA 92879. Dinner is $12.50 per person.

The Supplier Did What?!

All too often we realize (a bit too late) that for some reason suppliers have an impact on our products and services. As it turns out, ensuring the consistent supply of “good” parts and services is key to any business. But what should we do? And how far do we go before our process becomes too draconian? In this discussion we will go over some of the main elements any purchasing/supplier controls process should have as well as discuss some of the many ways these elements can be implemented.

Come and meet Michael Holcomb, Principal Supplier Quality Engineer with Boston Scientific Neuromodulation. Michael has 22 years of experience working in Quality for the nutritional supplement, drug/biotechnology, and medical device industries. He has worked in nearly every area in Quality, which includes 8 years in Supplier Quality. In that time he has seen just about every way a supplier quality system can be (and in some cases, shouldn’t be) implemented. He earned a Bachelor’s degree in Chemistry from California State University, Northridge. He is a Senior Member of ASQ and is an ASQ-certified MQ/OE.

Quality in Performance Management

Today’s economic climate and competitive marketplace demand peak performance from everyone involved, and each individual, from the mail room to the CEO, has the ability to affect change and drive business results. Join Gary Urban, Executive Director of Operations at Rx Research Services Clinical Research Organization (RxRS CRO) and explore his session on Quality in Performance Management to gain proven, holistic solutions to everyday performance management challenges.

The Difference Between Success and Failure in the Medical Device Business

Selecting Alternative Regulatory Pathways to Market

Orange County Regulatory Affairs Discussion Group

You are Invited to an Evening Meeting

The Difference Between Success and Failure in the Medical Device Business: Selecting Alternative Regulatory Pathways to Market

Wednesday, Oct. 24, 2012

Time:

6:00 pm – 8:00 pm

Location:

Alcon Laboratories
15800 Alton Pkwy
Irvine CA 92618

Presented by:

Evan L. Rosenfeld, MD JD FCLM

Vice President for Medical and Scientific Affairs

Theorem Clinical Research

Program Manager:

Christopher Swanson, Regulatory Affairs Specialist

Advanced Sterilization Products

Pricing:

$50 OCRA Members

$100 Non Members (includes OCRA Membership)

$25 Students/Government
Free for Alcon Employees
(email Rob Fleming to be added to the list:rob.fleming@yahoo.com)

Synopsis of the Session:

The choice and availability of a more attractive, alternative regulatory pathway to the U.S. marketplace often can make the difference between a medical device manufacturer’s financial and market success or failure. Thus, a medical device sponsor’s essential business viability – or lack thereof – can depend directly on both the existence and the successful use of such an unconventional approach to FDA, especially for young companies in their early stages of business development.

In a 1997 law, the “de novo downclassification process” was created to assist companies to bring to market their new, novel, and by definition “Class III,” medical devices by allowing clearance under the much less burdensome 510(k) regulatory route, instead of having to go down the difficult route of premarket approval (“PMA”). Ultimately, the ability to submit a far simpler 510(k) premarket application rather than having to go the PMA route can reduce time to market entry by several years and decrease up-front monetary costs by literally hundreds of thousands of dollars. The de novo process allows FDA to more quickly and more simply clear a new device for sale on the U.S. market despite the nonexistence of a predicate device to which the “new” device might be found substantially equivalent and, thus, which ordinarily requires a PMA. The de novo process instead only requires the manufacturer to develop and implement certain, far less expensive “special controls” that better guide the consumer (including physicians and/or patients) that are aimed at enhancing overall patient safety and minimizing potential device-related dangers to the public.

The current presentation includes a brief historical overview of the de novo process and its evolution to present day, provides a summary of companies that have used the de novo process successfully, outlines the timeline for this process, discusses the changes to the de novo process that have been implemented most recently, and analyzes the benefits to and the challenges still facing the medical device industry’s use of the de novo downclassification route for product regulation and ultimate entry to the U.S. market. Also to be discussed are the Agency’s recent parallel activities to – on its own initiative – downclassify several device types, as support for FDA’s real moves to assist device manufacturers to move their innovative products more expeditiously through the market clearance process and onto the U.S. sales market.

About the Speaker:

Evan L. Rosenfeld, MD JD FCLM

Vice President for Medical and Scientific Affairs

Theorem Clinical Research, Dallas TX

Dr. Rosenfeld is in charge of leading the company in its efforts to assist clients with their complex strategic clinical study design, implementation, completion, and review/interpretation of such trial results, from the various perspectives of:
* Optimizing regulatory pathways; Outcomes of governmental reviews for market clearance or approval; Post−clearance/approval market positioning (relative to potential and/or existing competitors); Long−term safety outcomes and assessments; and Overall scientific/clinical rigor of the clinical studies under advisement.

* Involvement at all stages of clinical trials, ranging from first−in−man and feasibility studies (to confirm and support continued product development efforts) to post−market trials (e.g., to support reimbursement activities, ongoing safety and efficacy monitoring, etc.).

* Involvement in all company business units, with predominant focus on medical device clients, including those with device−drug combination and in vitro diagnostic (IVD) products.

* Maintaining a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner. * Building thought leadership by participating in conferences, events, and client presentations. * Leading client meetings, conduct capabilities presentations, and leverage personal networks and Business Unit expertise.

He has his MD from Medical College of Virginia, his JD from University of Pennsylvania Law School and a BA in Biology from Harvard.

Directions from San Diego:Take I-5 N to Exit 94B. Take ramp right and look for signs for Alton Pkwy. Turn left onto Alton Pkwy. Make a u-turn at Telemetry and arrive 15800 Alton Pkwy. (If you reach Banting, you’ve gone too far.)

Cost of Quality (COQ) is a basic tool for quality practitioners. The name is somewhat misleading; some persons use the expression Cost of Poor Quality (COPQ). Regardless of name, COQ characterizes the costs that would disappear if the product or service was perfect. This presentation will include a historical overview, methods for collection, analysis and reporting of COQ and examples of its power.

SOCRA 21st Annual Conference September 21-23, 2012

Please join Rosemarie Christopher at the Society of Clinical Research Associates (SOCRA) 21st Annual Conference at the RIO All Suite Hotel in Las Vegas on September 21-23, 2012!

Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be affiliated with medical centers; cooperative research groups; research consortia; pharmaceutical, device, and biotechnology companies; contract research organizations; site management organizations; and independent research firms are all invited to attend. Register now!

Stop by MEIRxRS Exhibit Booth #10 for some goodies : )

Listen to Rosemarie Christopher present how to Manage a Multi-generational Workforce on Sunday, October 23rd at 10:10am

Earn Continuing Education Credit Hours

Network with over a thousand industry professionals in CRO, pharmaceutical, device and biotechnology companies

5S – reduce waste and improve your efficiency

The 5S philosophy focuses on effective workplace organization and standardize work procedures. A robust 5S program will reduce waste and improve your efficiency while improving quality and employee safety. 5S is based on Japanese words that begin with the letter “S.” The term 5S references the five elements of this system: Sort, Set i Order, Shine, Standardize and Sustain.

Join ASQ Section 711 members and guests on Wednesday, September 19, 2012 at 6:30pm at the Home Town Buffet (390 McKinley Avenue, Corona Hills Plaza, Corona, CA 92879) for networking, dinner and professional development!

Reservation not required. Cost is $12.50 per person. Let the server know that you are with the ASQ group.

Use Data to Drive Continuous Improvement

For the manufacturers to deliver a high quality product with low cost they must have an effective Continuous Improvement program. Continuous Improvement objective is to reduce the process variation. Reducing the process variation not only helps the manufacturer to compete but also to comply with the FDA requirement. FDA requires the manufacturers to have an effective CAPA system. CAPA (Corrective Action Preventive Action) is a quality system to reduce the production process errors.

Come and learn the following continuous improvement tools and techniques:

1. SIPOC is the Process morphology
2. How to optimize the process, and what tools to use
3. How to monitor and investigate nonconformance

Dietary Supplement Challenges: cGMPs, Analytical, FSMA,NDI, and More

The Food, Drug & Cosmetic Division of the American Society for Quality in cooperation with the United States Food and Drug Administration, Los Angeles District and the California Department of Public Health presents the 22nd Annual ASQ FDC West Coast Conference!

Quality Professionals Can Help Drive Improvement in Delivery

With many quality organizations focusing on improving PPM, there has been a lapse in efforts supporting the recovery of critical past due items. With Lean Manufacturing touted as the preeminent method for reducing lead times, and/or improving long term On Time Delivery (OTD), short term recovery efforts have not been developed and documented in a systematic approach. This presentation will serve as a foundation for recovery planning, with the notion that each recovery is unique, and will by nature have its own characteristics.

Achieving optimal reimbursement and market access is a critical success factor for any new health technology in today’s cost-constrained marketplace. While gaining reimbursement is viewed by some organizations as simply a barrier to success that needs to be overcome, many companies are seeking to use their market access capability as a means of positively differentiating the company and their products from the competition.

Even for companies who have no plans to commercialize their new technology themselves, having a well thought out and achievable market access strategy that complements the clinical development strategy, can add significantly to the value of their assets.

Beginning with a thorough understanding global payer needs and evidence requirements, through identifying points of economic leverage, building a compelling value story and generating a robust foundation of evidence, this session will take the participant through a step by step review of the key components of a strategic market access plan.

In addition, the session will identify key challenges to implementation of the strategy by providing a solid understanding of current coding, coverage and payment, and reviewing how best to create and communicate compelling value messages for the key stakeholder audiences.

As usual, there will be ample time for a Q&A session and opportunity to network with your industry colleagues.

Your Products and the Environment: Responsibilities and Stewardship
Regulations are expanding the controls needed for the complete lifecycle of a product from the point of feasibility and raw materials to the disposal of the product and its wastes. This session covers challenges that regulatory affairs professionals face in today’s global environment. Regulations on raw materials, component parts, waste management, and chemical hazards all complicate medical device product lifecycles.

The targeted audience for this session is new and mid-level regulatory affairs specialists and environmental impact analysts who are responsible for a wide variety of products and need to understand the regulations that govern them. The impact of regulations on medical devices with electronic and chemical components will be the focus of this session. Effective cost and process management that links different regulations and products will be explored.

Mary graduated with a bachelor’s in Biology from the University of California at San Diego. Mary has been with Baxter since 2005 as BioScience Division CAPA Manager and is responsible for the division CAPA program in 15+ sites throughout the US and Europe. Among her responsibilities, Mary is a certified Lead Investigator trainer responsible for training potential CAPA owners, approvers, and other trainers. Prior to her current position at Baxter, was had extensive leadership experience in the biotechnology and medical device industries.

Abstract:
Which Data Streams You Should be Analyzing and How: There are an overwhelming number of data streams that can be analyzed and reported on. How do you sort the “essential” and focus on them? Do these reported data streams stay the same through the years, or do they evolve as your industry, company, and regulatory climate evolves?

This interactive session will identify which data streams you should use to gauge the health of your products and quality system and how to measure and report them in a way that will be understood by those who review them.

Takeaways

– Identify which data streams you should use to gauge the health of your products

– Identify which data streams you should use to gauge the health of your Quality system

– How to measure and report that data in a way that will be understood by those who review it

Niedre Heckman is a Quality Management professional with nearly two decades of hands on expertise in quality assurance, quality control, regulatory affairs and research and development. She is a process oriented leader with diversity of experience across medical products. She couples experience in quality systems and regulatory compliance with business acumen to develop strategic solutions that achieve organizational goals.

Currently, Niedre works in Regulatory Affairs at Baxter Healthcare Corporation. Prior to this, she worked for 3M in Quality and in Regulatory Affairs positions.

Niedre is involved with the professional organizations ASQ and RAPS, where she holds the CQA and RAC certificates, respectively. Niedre has an MS in Chemistry from UC Irvine and an MPH from UCLA.

Dr. Kumari Devulapalle, has extensive experience in biochemistry and biotechnology both in academics and biopharmaceutical industry over 20 years. She has contributed to different NIH grants on enzyme kinetics and protein modeling during her work at University of Southern California before she moved to Amgen analytical R & D on method development and validation for therapeutic biomolecules.

She has been working for the past 8 years at 3M Northridge, in quality control aspects of the biopharmaceuticals where she is leading the implementation of Six Sigma Lean projects. She is also known in adapting Right The First Time, analytical method improvements for product testing and release.

Abstract:

The majority of drug products are not discretionary and are often urgently needed. Depending on the type of product, for example biologics, shelf-life and storage factor into the urgency of getting products to the customer. Thus, there is a business need and responsibility to provide high quality products in a reasonable, and sometimes expedited, manner. This presentation considers best practices for getting drug products to the customer in two areas: (1) Product release of pharmaceuticals from the Quality Assurance Unit, and (2) Global product registration enabling world-wide product accessibility to customers. This audience interactive session will provide some dashboard metrics used to ensure processes for efficiently getting product to customers are tracked for continuous improvement. The session will also bring awareness to some of the interesting details that can slow down the process.

Takeaways

General understand of metrics than can be applied to product release and product global expansion

Tools that can be implemented in a high-volume quality control laboratory

Awareness of how US compliance issues can slow down or stop global expansion

In 2011 over 87% of FDA warning letter citations involved record deficiencies. FDA officials say, “If you didn’t document it, it didn’t happen. In God we trust, for everyone else we require documentation.”

Every document that is written on a company computer during company time becomes a company record. As a result of multi-million dollar lawsuits, industry leaders have learned that a seemingly innocuous phrase like “This will negatively impact the bottom line” in an email from an employee can undermine their organization’s credibility. The thousands of emails sent on a daily basis can be retrieved indefinitely.

During this session, Nancy Singer of Compliance-Alliance, Helene Spencer from ClinReg Consulting Services, Inc. and Dan Solis from FDA will lead a high-energy interactive session. Attendees will be divided into teams; through case studies, real life examples and exercises, they will discover how to ensure that their written correspondence reflects the depth of their organization’s culture of compliance. Specifically, the training will cover:

Program Manager: Terrie Hopton, BS, CCRP, Manager, Business Development and Special Projects, Promedica International

Cost:
$50 OCRA Members
$100 Non Members (Includes OCRA 2012 Membership)
$25 Government and Students (Student Rate is for Full-time students only. Student ID and copy of current class schedule required to register).

A presentation by Ron Nash Founder, Dream Job University Ron Nash is author of the first comprehensive online LinkedIn training, Leveraging LinkedIn. His latest book, “Leveraging LinkedIn: The Essential Guide To Your Career Network” was published in July of 2012. Ron has helped the Fortune 500 companies Microsoft, T‐Mobile, The Anthony Robbins Companies, Samsung, Cardinal Health, Biogen‐Idec, and others leverage social media as a business and career development tool. Ron has presented his concepts to audiences nationwide at UCLA, UCSD, AACS, CEA, and ITT Technical Institute. Through working with individuals tp achieve business and life success, he has collaborated with Cesar Millan, “The Dog Whisperer”, Deepak Chopra, Eckhart Tolle, and numerous others. Ron lives in San Diego California with his wife, two children, two cats (Yin &amp; Yang) and their beloved dog, Buddha.

Two books will be raffled to participants at the presentation. Come with your most pressing LinkedIn questions for Ron.

ASQ S706 50th Anniversary Celebration

August 10, 2012 at 6:00 PM – 9:00 PM

Rancho San Antonio, Chatsworth

~registration closed ~

Your ASQ Section turned the Big Five-Oh this year! That?s right, fifty, half a century. Come celebrate this auspicious occasion with your fellow members and friends. Walk down Memory Lane with the Board as we reminisce about things long past and not so long ago. Possibly an honored guest or two will surprise us. Feel free to bring your personal memorabilia for sharing stories from your era. If you know of a past member who might be interested but whose information is no longer available through ASQ Membership, please pass along this invitation so that they are not left out of the festivities. Contact Carole Elm (see above) if you have any questions. San Fernando Valley 706 was officially chartered as a section of American Society for Quality Control (ASQC) in May 1962.

YES YOU CAN!

Find the Right Fit Job

On May 22, 2012, hear from Bret Pfost, Senior Safety Manager, Disneyland Resort and Rosemarie Christopher, President & CEO of MEIRxRS who have mastered attracting, recruiting and retaining top scientific and technical talent. Tap into their expertise and learn how to not only have the right skills for the job but the right “everything else” that employers look for when hiring their next employee.

Join us at the American Society for Quality (ASQ) World Conference for Quality and Improvement (WCQI) Career Fair at the Anaheim Convention Center Exhibit Hall A.
Register now at http://www.eventbrite.com/event/2945254335 to reserve your seat.

YOU BE THE JUDGE

One truck load of contaminated spinach can ruin your day…

as well as your organization’s reputation, workforce morale and bottom line.

On May 22, 2012, jump in the jury box and witness Frank Rothrock and Eva Weiler of Shook, Hardy & Bacon, Alonza E. Cruse of the U.S. Food and Drug Administration and Kellie Moore of MEIRxRS as they host a mock deposition demonstrating how to offensively prepare witnesses and investigate compliance practices.

Not for the queasy, this expert team will show you how your conduct can make or break your defense utilizing the reality, risks and perils of contaminated food.

Join us at the American Society for Quality (ASQ) World Conference for Quality and Improvement (WCQI) Mock Deposition at the Anaheim Convention Center Exhibit Hall A. Register at http://www.eventbrite.com/event/2945254335 to reserve your complimentary seat.

Tap into their expertise and learn how to engage, empower and foster employee accountability to generate productivity and profitability when working with multi-generational workers – Millennials to Gen X/Y and Boomers.

Join us at the American Society for Quality (ASQ) World Conference for Quality and Improvement (WCQI) Career Fair at the Anaheim Convention Center Exhibit Hall A. Register now at http://www.eventbrite.com/event/2945254335 to reserve your complimentary seat.

Mock Deposition at the ASQ WCQI Career Fair

Producing Results through an Engaged Workforce

According to Gallup Polls, today’s organizations consist of 29% actively engaged workforce, where employees have a higher level of performance and productivity that result in greater customer satisfaction and profitability for the organization. The remaining 71% of the workforce are disengaged and dissatisfied, costing organizations an annual loss of $350 billion dollars in productivity and revenue.

Management can change the engagement level of their workforce and improve productivity. Register now* to join us on Tuesday, May 22, 2012 at the American Society for Quality (ASQ) World Conference for Quality Improvement (WCQI) Career Fair at the Anaheim Convention Center Exhibit Hall.

Come and network with industry professionals and learn how to find the Right Fit Job!

1:30 pm – 2:30 pm The “Right Fit” Job: Find your best job ever! Bret Pfost, Senior Safety Manager, Disneyland Resort, will share the importance of not just having the right skills for the job, but the right “everything else” that employers look for when hiring their next employee.

MEIRxRS (Recruiting, Staffing, CRO) will be giving away FREE DISCUS work personality profiles ($37 value) to the first 100 unemployed professional, student and veteran career fair attendees who pre-register to this session. Register now at http://tinyurl.com/83k9znp.

Mock Trial Deposition Luncheon-litigation team from Shook, Hardy & Bacon, led by Paul La Scala, Partner, will skillfully demonstrate how to properly prepare your documentation for compliance to standards and regulations.

Host/Moderator: Kellie Moore, General Counsel, MEIRxRS

Job Seeker Program: The “Right Fit” Job-find your best job ever! Bret Pfost, Senior Safety Manager, Disneyland Resort, will share the importance of not just having the right skills for the job, but the right “everything else” that employers look for when hiring their next employee.

Host/Moderator: Rosemarie Christopher, President & CEO, MEIRxRS

MEIRxRS will be giving away FREE DISCUS work personality profiles ($37 value) up to 100 Career Fair attendees who pre-register to this session.

CSUN Career Skills Workshop

Can you earn top dollar?
Can you showcase your skills?
Can you communicate your worth?

The workshop is an interactive session in which attendees learn to create their ‘self brand.’ In this exercise, they answer the question: “What workplace behaviors guarantee that my career will be ‘fast tracked’?

Meet and network with Industry Professionals
Learn how to develop your career
Mock Interview Sessions with potential employers

The Mock Interview Session simulates real life interview sessions by affording attendees the opportunity to practice interviewing techniques that will showcase their workplace skills and ‘self brand’ to Quality, Engineering, Supply Chain, R&D and other career professionals from the San Fernando Valley’s most forward moving companies in Technology (Industrial, Space and Information), Medicine, Healthcare, Military and Commerce.